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510(k) Data Aggregation
K Number
K170058Device Name
TheraView TBI
Manufacturer
Date Cleared
2017-03-03
(56 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
Cablon Medical B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Digital Portal imaging system designed to allow pre-treatment verification and real time viewing of the radiation therapy treatment. Images maybe stored to hard disk for processing, analysis and hardcopy. This includes an automated border detection for field size and shape verification and a semi-automated overlay function of an anatomical template reference adding enhanced level of on-line assurance for image verification and comparison.
Device Description
Digital Portal imaging system designed to allow pre-treatment verification and real time viewing of the radiation therapy treatment. Images maybe stored to hard disk for processing, analysis and hardcopy. This includes an automated border detection for field size and shape verification and a semi-automated overlay function of an anatomical template reference adding enhanced level of on-line assurance for image verification and comparison.
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